Application 088109
- Type
- ANDA
- Sponsor
- ROXANE
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 002 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0054-0710 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0710 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0710 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0710 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
Documents
| Document | Title | Submission type | Submission no. | Date |
|---|---|---|---|---|
| 76460 | 0 | ORIG | 1 | 2023-11-07 |